(16 days)
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No
The device is a patient examination glove, a simple barrier device. The description and performance data focus on physical properties and biocompatibility, with no mention of AI or ML.
No
A patient examination glove is intended to prevent contamination, not to treat or cure a disease or medical condition.
No
The device is described as a "patient examination glove," which is used to prevent contamination between patients and examiners, not to diagnose a medical condition.
No
The device is a physical patient examination glove, not a software application. The description focuses on material properties and performance tests related to a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical properties and standards met by the glove (latex, powdered, ASTM standards, FDA water leak test). This aligns with a medical device used for protection and hygiene, not for in vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro examination.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves based on ASTM D3578-01a22 and FDA 1000 ml watertight test.
TEST: Watertight (1000 ml), ASTM D3578-01aE2: AQL=2.5%, POWDERED LATEX EXAM GLOVES: Pass GI.
TEST: Length (mm), ASTM D3578-01aE2: Min 230 for Sizes XS, S, M, L, XL, POWDERED LATEX EXAM GLOVES: 240 mm minimum for all sizes.
TEST: Palm width (mm), ASTM D3578-01aE2: Size XS '-', S 80 +/- 10, M 95 +/- 10, L 111 +/- 10, XL '-', POWDERED LATEX EXAM GLOVES: 110 mm for XL.
TEST: Thickness (mm) (Single Layer) Finger, ASTM D3578-01aE2: Min 0.08, POWDERED LATEX EXAM GLOVES: 0.10 minimum.
TEST: Thickness (mm) (Single Layer) Palm, ASTM D3578-01aE2: Min 0.08, POWDERED LATEX EXAM GLOVES: 0.10 minimum.
TEST: Physical Properties Before Aging Tensile Strength (Mpa), ASTM D3578-01aE2: Min 14.0, POWDERED LATEX EXAM GLOVES: *28.0 (average result obtained from Attachment C).
TEST: Physical Properties Before Aging Ultimate Elongation (%), ASTM D3578-01aE2: Min 650, POWDERED LATEX EXAM GLOVES: *982 (average result obtained from Attachment C).
TEST: Physical Properties After Aging Tensile Strength (Mpa), ASTM D3578-01aE2: Min 14.0, POWDERED LATEX EXAM GLOVES: *26.9 (average result obtained from Attachment C).
TEST: Physical Properties After Aging Ultimate Elongation (%), ASTM D3578-01aE2: Min 500, POWDERED LATEX EXAM GLOVES: *970 (average result obtained from Attachment C).
TEST: Powder Content, ASTM D3578-01aE2: '-', POWDERED LATEX EXAM GLOVES: Below 10 mg / dm2.
TEST: Protein Content, ASTM D3578-01aE2: '-', POWDERED LATEX EXAM GLOVES: Below 200 microgram / dm2.
The performance data of the glove as showed above meet the ASTM D3578-01a"2 8. Standard and FDA's requirement. Powder content is below 10 mg per dm², which meet the FDA Requirements.
The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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MAR 1 8 2005
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
1.0 SMDA 510 (K) SUMMARY
| 2.0 | Submitter | SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8,
Greentown Business Centre
30450 Ipoh, Perak, Malaysia. |
|-----|--------------------------|----------------------------------------------------------------------------------------------------------------|
| | Tel | (60 5) 322 3200 |
| | Fax | (60 5) 322 2300 |
| | Name of Contact Person | Ms. CHUN CHOOI FONG |
| | Date of Summary Prepared | February 14, 2005 |
| 3.0 | Name of Device | |
| | Device Name | Powdered Latex Examination Gloves |
| | Common Name | Exam Glove |
Classification Name Latex Patient Examination Glove
4.0 Identification of the Legally Marketed Devices
Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a22 and FDA requirements.
5.0 Description of The Device
Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
6.0 The Intended Use of Glove
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Page 1 of 3 ATTACHMENT L
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SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
7. Summary of Performance Data:
Performance data of gloves based on ASTM D3578-01a22 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-01aE2 | POWDERED LATEX EXAM GLOVES | |
|---|---|---|---|
| AQL=2.5% | Pass GI | AQL=2.5% | |
| 1. Watertight (1000 ml) | GI | ||
| 2. Length (mm) | |||
| Size XS | Min 230 | 240 mm minimum for all sizes | |
| S | Min 230 | ||
| M | Min 230 | ||
| L | Min 230 | ||
| XL | Min 230 | ||
| 3. Palm width (mm) | |||
| Size XS | - | 110 mm | |
| 4. Thickness (mm) | |||
| (Single Layer) | |||
| Finger | Min 0.08 | 0.10 minimum | |
| Palm | Min 0.08 | 0.10 minimum | |
| 5. Physical Properties | |||
| Before Aging | |||
| Tensile Strength (Mpa) | Min 14.0 | *28.0 | |
| Ultimate Elongation (%) | Min 650 | *982 | |
| After Aging | |||
| Tensile Strength (Mpa) | Min 14.0 | *26.9 | |
| Ultimate Elongation (%) | Min 500 | *970 | |
| 6. Powder Content | - | Below 10 mg / dm2 | |
| 7. Protein Content | - | Below 200 microgram / dm2 |
- The average result obtained from Attachment C.
2
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
- The performance data of the glove as showed above meet the ASTM D3578-01a"2 8. Standard and FDA's requirement. Powder content is below 10 mg per dm², which meet the FDA Requirements.
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Powdered Latex Examination Gloves meet the below specifications:
- ASTM D3578-01a52 Standard -
- FDA pinhole requirements -
- FDA minimum powder residual content --
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its back, representing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Chun Chooi Fong Quality Management System Manager SPI Gloves SND. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak, Darul Ridzuan MALAYSIA
Re: K050527
Trade/Device Name: Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 28, 2005 Received: March 2, 2005
Dear Ms. Chooi Fong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Chooi Fong
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I Dr. 5 issuained on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I cucral statues and regaraters, including, but not limited to: registration 1 ou must comply with an the Hoseng (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), lacems (QS) regulation (21 CFR Part 820); and if requirenents as set form in the quality of other (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mationing your substantial equivalence of your device to a premarket notification. "The PDF mailing or clossification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for Jour at (240) 276-0115. Also, please note the regulation presse contact the Other or Some to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorinational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saute Michie. Oatis.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
: SPI Gloves Sdn. Bhd. Applicant K050527 510(K) Number :
Device Name : Powdered Latex Examination Gloves With Protein Labeling Claim (Contains 200 micrograms or less of Total Water Extractable Protein per Gram)
Indication For Use:
A patient examination glove is a disposable device intended for medical purposes that is A patient examiner's hands or finger to prevent contamination between patient and examiner.
Prescription Use: ......................... (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter ...........X.......... (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheila V. Murphy, L.S.
Anticlogy, General Hospital
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